Thermogard
Thermogard Pediatric Dual Dispersive Electrode, Contact Quality Monitor
65manufacturers in China registered for this device type
9catalogue numbers in this listing
25510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K140658 |
| Record published | 2016-09-24 |
| Record revised | 2024-08-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 32 °C; Storage environment temperature 50 to 90 °F; Storage environment humidity 10 to 90 % RH |
| Packaging | Box of 80, box of 40, pack of 40, box of 10 |
| Distribution end date | 2023-01-10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 51-7810 | 80 | In distribution | |
| 51-7410 | 80 | In distribution | |
| 7-384 | 40 | In distribution | |
| 51-7710 | 80 | In distribution | |
| 7-382 | 40 | In distribution | |
| CRA-SGP | In distribution | ||
| 51-7910 | 80 | In distribution | |
| 51-7310 | 80 | In distribution | |
| 7-382 | 40 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 5,729 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5,212 |
| Stingray Surgical Products | Stingray Surgical Products L.L.C. | 4,647 |
| Kirwan | Kirwan Surgical Products, LLC. | 1,901 |
| Millennium | Avalign Technologies, Inc. | 1,779 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 1,590 |
| Elmed | Elmed, Inc. | 1,519 |
| Symmetry Olsen | Aspen Surgical Products, Inc. | 1,219 |
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 1,117 |
| Ambler Surgical | Ambler Surgical, LLC | 756 |
| V. Mueller | Steris Corporation | 661 |
| Aesculap | Aesculap AG | 544 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231732 | 2023-10-23 |
| K230547 | 2023-04-27 |
| K214058 | 2022-08-26 |
| K221945 | 2022-07-28 |
| K213354 | 2022-03-11 |
| K172671 | 2017-10-04 |
| K151229 | 2016-06-02 |
| K152860 | 2015-12-29 |
| K153499 | 2015-12-18 |
| K140578 | 2014-07-23 |
| K140459 | 2014-07-11 |
| K140658 | 2014-07-10 |
| K123260 | 2012-12-21 |
| K120476 | 2012-06-12 |
| K120322 | 2012-06-12 |
| K103665 | 2011-02-16 |
| K100686 | 2010-05-21 |
| K100047 | 2010-05-14 |
| K081644 | 2008-09-10 |
| K081634 | 2008-06-25 |
| K081580 | 2008-06-19 |
| K062082 | 2007-01-25 |
| K052104 | 2005-10-21 |
| K052009 | 2005-09-28 |
| K041868 | 2004-09-28 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ConMed Corporation | 510(k) number | 2016-05-18 | Class II | Device Design | A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. | 307,684 units | 2018-05-24 |
| ConMed Corporation | 510(k) number | 2016-05-18 | Class II | Device Design | A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. | 4,480 units | 2018-05-24 |
| ConMed Corporation | 510(k) number | 2016-05-18 | Class II | Device Design | A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. | 6,640 units | 2018-05-24 |
| ConMed Corporation | 510(k) number | 2016-05-18 | Class II | Device Design | A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. | 124,333 units | 2018-05-24 |
| ConMed Corporation | 510(k) number | 2016-05-18 | Class II | Device Design | A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. | 4,560 units | 2018-05-24 |
Recalls
33 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-11-18 | Class II | Process control | Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to | 23,700 US; 5,225 OUS | 2026-04-13 |
| 2017-02-28 | Class II | Mixed-up of materials/components | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to | ||
| 2017-02-28 | Class II | Mixed-up of materials/components | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to | ||
| 2017-02-28 | Class II | Mixed-up of materials/components | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to | ||
| 2017-02-28 | Class II | Mixed-up of materials/components | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to | ||
| 2017-02-28 | Class II | Mixed-up of materials/components | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to | ||
| 2015-11-05 | Class II | Process control | Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece’s temperature. This causes some devices to generate a “Check Seal” message with an audible a | 9 devices | 2018-05-24 |
| 2015-06-17 | Class II | Software design (manufacturing process) | Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage. | 276 devices | 2017-04-11 |
| 2014-05-08 | Class II | Nonconforming Material/Component | ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed. | Domestic – 12,600 units, Foreign – 44,280 units | 2017-04-11 |
| 2014-02-20 | Class II | Device Design | ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns. | 12,653 units (10,769 domestically & 1,884 internationally) | 2017-04-07 |
| 2013-10-23 | Class II | Material/Component Contamination | The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk | 147 handpieces (Domestic: 135 devices; Foreign: 12 devices) | 2017-03-08 |
| 2013-10-23 | Class II | Material/Component Contamination | The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk | 65 handpieces (Domestic: 41 devices; Foreign: 24 devices) | 2017-03-08 |
| 2013-01-28 | Class II | Equipment maintenance | Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. | Domestic Distribution: 97,450 units; Foreign Distribution: 6 | 2017-04-11 |
| 2013-01-28 | Class II | Equipment maintenance | Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. | Domestic Distribution: 97,450 units; Foreign Distribution: 6 | 2017-04-11 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-05-07 | Not classified | Equipment maintenance | An investigation of the ConMed Electrosurgery Altrus Energy Source revealed that the device could have been calibrated incorrectly resulting in error messages or delays in surgery. | 122 units | 2012-06-19 |
| 2012-05-07 | Not classified | Process control | The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding. | 18 units | 2012-06-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.